Florida Board of Pharmacy rule amends requirement for hours of operation

Florida community pharmacies no longer must operate at a minimum of 40 hours per week, thanks to a Florida Board of Pharmacy rule change. Late last month, the board amended the rule regulating hours of operation to read: “Any person who receives a community pharmacy permit pursuant to Section 465.018, F.S., and commences to operate such an establishment, shall keep the prescription department of the establishment open for a minimum of twenty (20) hours per week.â€

The previous rule required community pharmacies to keep their prescriptions department open for 40 hours.

The rule change is significant for smaller pharmacies because it reduces the tremendous financial burden of maintaining the pharmacy and having a pharmacist on duty for the previously required 40 hours.

As with the previous rule, the pharmacy must post its hours and have a procedure in place to transfer prescriptions and address emergencies. The new rule reads:

“At the time a pharmacy commences to operate, a sign in block letters not less than one-inch in height stating the hours the prescription department is open each day shall be displayed either at the main entrance of the establishment, or at or near the place where prescriptions are dispensed in a prominent place that is in clear and unobstructed view. Any pharmacy that is not open 40 hours a week, must post the days and hours that the pharmacy is open and the information for after-hours access and shall also have a written policy and procedure for transferring a prescription.â€

The rule change also allows community pharmacies to delay opening for business after receiving a pharmacy permit, but they must notify the board office in writing, within 14 days of receiving a Florida pharmacy permit, of its election to delay operations and the reason(s) for the delay.

If the business does choose to delay the commencement of business it must:

• Display a sign in block letters not less than one inch in height at the main entrance of the establishment stating that the pharmacy is not yet open for business and that medicinal drugs may not be dispensed or sold nor prescriptions filled or dispensed.
• Within two business days of commencement of operations, the permittee shall notify the board office in writing that the permittee has commenced to operate and the date of commencement.

Any pharmacy that fails to begin to operate within six months of having received a Florida pharmacy permit must provide a written statement to the board office that includes the reason(s) the pharmacy has not yet begun operations, the efforts that have been made to begin operations, and the date the pharmacy expects to open for business.

In July, the Florida Board of Pharmacy amended its ownership rules to clarify that, for pharmacy permits held by business entities, the change of ownership of the entity does not itself require the issuance of a new permit unless the identity of the entity changes.

Upon transfer of the ownership interests in the business entity, the following steps must be taken:

• Within fifteen days of closing the transfer, the permittee shall notify the board office of the transfer of ownership interests; and,
• As specified in Section 465.022(3), F.S., all persons, members, partners, officers, directors, and agents having an ownership or other financial interest of greater than five percent, and all persons who directly or indirectly manage, oversee, or control the operation of the business entity, must file with the board a set of fingerprints.

A change in ownership (and issuance of a new permit number) requires that new records be started and old records closed. The process for closing a pharmacy, including the transfer of prescription files and medicinal drugs, must be followed for the old permit. If the old permit has controlled substances, the new permit must record an “opening inventory†for DEA purposes. Both the new permit and the old permit must keep appropriate records for four years for the transfer of legend drugs and controlled substances.

A change in the company or person who leases the building where the permit is housed, or a change in the management company which contracts with the owner of the permit for the operation of the permit, does not constitute a change in ownership.

The Health Law Offices of Anthony C. Vitale represents pharmacies in all matters regarding licensure, overpayments and audits. If you have any questions or concerns, feel free to contact our offices at 305-358-4500 or email us at info@vitalehealthlaw.com.